CORTECS INTERNATIONAL ESTABLISHES CLINICAL LINK TO DEVELOP CORTECS' ORAL FORMULATION OF INSULIN.LONDON--(BUSINESS WIRE)--June 24, 1996--Cortecs International ("Cortecs") (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :DLVRY)(LSE LSE - Language Sensitive Editor :COR)(ASX ASX See: Australian Stock Exchange :CRI CRI constant-rate infusion. ) today announced that it has entered into an agreement with Osteometer Biotech A/S and with the Centre for Clinical and Basic Research ("CCBR CCBR Canadian Conference on Broadband Research CCBR Configuration Control Board Request ") for the clinical development of an oral formulation of insulin for the management of diabetes mellitus diabetes mellitus Disorder of insufficient production of or reduced sensitivity to insulin. Insulin, synthesized in the islets of Langerhans (see Langerhans, islets of), is necessary to metabolize glucose. In diabetes, blood sugar levels increase (hyperglycemia). . Insulin is a peptide, which currently has to be injected in spite of many efforts to find improved delivery methods since its discovery in the 1920's. Under the agreement, Osteometer and CCBR will, in return for a royalty on sales, organize and execute at their own cost the clinical test of oral insulin to generate the clinical data required for registration applications in Europe. During the last five years Cortecs has been working to optimize its oral formulation of insulin with the objective of achieving more efficient and consistent delivery. In diabetes, consistency of delivery can be important and, until recently, the Company's focus had been primarily the advance of oral calcitonin calcitonin /cal·ci·to·nin/ (-to´nin) a polypeptide hormone secreted by C cells of the thyroid gland, and sometimes of the thymus and parathyroids, which lowers calcium and phosphate concentration in plasma and inhibits bone resorption. for the treatment of osteoporosis. During 1996, through further advances in its technologies, the Company has been able to achieve in pigs a high level of consistency with oral insulin as well as further improving efficiency and has therefore decided to re-commence testing in humans this summer. On April 10, 1996 Cortecs announced positive results of the first Phase II clinical trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored phase II in Europe of the oral delivery of another peptide, its oral calcitonin formulation for the treatment of osteoporosis. Estimations of diabetes prevalence around the world have more than tripled since the mid-1980s. In 1985 WHO estimated that 30 million people around the world were afflicted. By 1989, the figure had risen to 50 million. In 1991 WHO stated that "an apparent epidemic of diabetes has occurred - or is occurring - in adult people throughout the world" and the figure is now estimated to be 100 million. The cost of managing diabetes has risen sharply and can take up to as much as 10% of national health budgets. Diabetes is considered the third most expensive disease state in man behind cancer and heart disease costing the US over $90 billion annually. Diabetes is generally divided into two classes, known as Type I (IDDM IDDM abbr. insulin-dependent diabetes mellitus IDDM insulin-dependent diabetes mellitus. IDDM Insulin-dependent diabetes mellitus; now known as type 1 diabetes mellitus ) and Type II (NIDDM NIDDM abbr. non-insulin-dependent diabetes mellitus NIDDM non-insulin-dependent diabetes mellitus. NIDDM Non-insulin-dependent diabetes mellitus. See Type 2 diabetes mellitus. ). Type I patients require insulin to survive, Type II patients may be managed with diet and drugs other than insulin, although insulin may form a part of the regime in some patients and may be extensively used in Type II patients were it to become available in the oral form. Type II patients make up over 80% of all diabetics. Current sales of insulin by injection are estimated at US$1.8 billion worldwide. Dr. Michael Flynn, President and Executive Director of Cortecs International, commented: "We are very happy with our existing agreements with Osteometer and CCBR which provide a cost-effective mechanism for each organization to concentrate on its special strength while leaving Cortecs free to enter commercial agreements with substantial marketing partners. We believe that positive results in human tests with Insulin would further demonstrate the enabling aspects of our delivery technologies, as well as providing a substantial opportunity to improve the management of diabetes. The move from animals into man, is a large step but, because of the similarity of size and of the structure of the small intestine of pig and man, and the new flexibility created by our recent 46 million pound fund raising we can advance with confidence into human tests. Our first test will be in healthy volunteers after which we will involve patients with Type II diabetes Type II diabetes Type II diabetes is the most common form of diabetes and usually appears in middle aged adults. It is often associated with obesity and may be delayed or controlled with diet and exercise. Mentioned in: Diabetic Ketoacidosis ." Professor Claus Christiansen, Director of Osteometer and of CCBR, said: "If insulin can be made orally effective with good consistency, then it would surely have a major place in the future management of diabetes. Cortecs has persevered with its insulin program for many years and recent tests in pigs give reason for some optimism that the program could succeed. If effective consistent delivery is shown in the first human test, the probability that this program will succeed becomes very high." Cortecs is a British-based company quoted on the London Stock Exchange London Stock Exchange London marketplace for securities. It was formed in 1773 by a group of stockbrokers who had been doing business informally in local coffeehouses. , the Australian Stock Exchange Australian Stock Exchange (ASX) Australia's major securities market, formed when the six state stock exchanges (Adelaide, Brisbane, Hobart, Melbourne, Perth, and Sydney stock exchanges) were merged in 1987. and on NASDAQ. The Company specializes in the development of new pharmaceutical delivery systems and point-of-care rapid diagnostics which provide the opportunity to advance the management of serious diseases such as: OSTEOPOROSIS Oral Calcitonin - an oral therapy for the prevention of bone breakdown. In Phase II. Osteosal - a rapid doctors' office test in collaboration with Osteometer to detect increased bone breakdown indicating the risk of the disease osteoporosis and also to monitor the adequacy of therapy. In development. HELICOBACTER PYLORI Helisal - a rapid doctors' office whole blood test for the detection of Helicobacter pylori in the market and a rapid saliva test in development. HELICOBACTER PYLORI Oral Therapeutic Vaccine in development to stimulate immunity. Oral Therapeutic in research to improve eradication results. DIABETES Oral Insulin - human tests planned in 1996. Glycosal - a rapid doctors' office test in collaboration with Exocell to assist in the management and identification of diabetics. In development. CYSTIC FIBROSIS Pseudostat - oral therapeutic antigens to treat and prevent lung infection with Pseudomonas aeruginosa. Entering Phase II trials in 1996. INFLUENZA Flustat - an oral vaccine against influenza. Entering human trials in 1996. THRUSH Moniliastat - an oral therapeutic vaccine against vaginal thrush. Enters human trials in 1996. DIARRHOEA Adept - an oral system to treat diarrhoea without antibiotics. Entering Phase II trials. MALE HORMONE DEFICIENCY Halo Testosterone - an oral male hormone replacement therapy Hormone Replacement Therapy Definition Hormone replacement therapy (HRT) is the use of synthetic or natural female hormones to make up for the decline or lack of natural hormones produced in a woman's body. in development to treat male hypogonadism. Cortecs also markets a range of ethical and OTC OTC See: Over-the-counter. OTC See over-the-counter market (OTC). medicines and diagnostic products. -0- NOTE TO EDITORS: Press releases and other Cortecs International Limited information are available on the Cortecs International Limited web site: http://www.cortecs.com. CONTACT: Mr. Glen Travers, Executive Chairman Cortecs International 011 44 181 568-7071 or Zena Bates Bates , Katherine Lee 1859-1929. American educator and writer best known for her poem "America the Beautiful," written in 1893 and revised in 1904 and 1911. / Ms. Lisa Baderoon Buchanan Communications 011 44 171 489-1441 or Van Negris Kehoe, White, Savage & Co., Inc. (212) 888-1616 |
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